Randomized Trial Comparing Two Sirolimus-Eluting Stents in Diabetes Mellitus

NCT ID: NCT04660240

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 860 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2025-09-01

Brief Summary

Randomized, controlled, blind, single-center and non-inferiority clinical trial to compare the target lesion failure (TLF) at 12 months in patients with diabetes mellitus who underwent percutaneous coronary intervention with an Orsiro stent vs. Abluminus stent.

Detailed Description

Worldwide, and especially in Mexico, there is a high incidence of diabetes mellitus (DM), which in turn, confers a higher cardiovascular risk in this population. Diabetic patients undergoing PCI have worse outcomes than non-diabetics regardless of the degree of complexity of their coronary anatomy. Although the 30-day in-hospital outcomes have been similar between diabetic and non-diabetic patients, DM has been invariably associated with greater stent failure with target vessel revascularization (TVR), major adverse cardiovascular event (MACE), and mortality in the long-term follow-up, even with the use of drug-eluting stents. In relation to the above, two of the sirolimus-eluting stents (SES): the Abluminus and the Orsiro, have been considered as promising options in patients with DM. The Abluminus stent has been designed for diabetic patients in order to reduce cardiovascular events. Said stent consists of a cobalt-chromium platform covered with a layer of biodegradable polymer and mounted on a balloon, both sirolimus-releasing. The Rate of target lesion failure (TLF) reported to date in diabetic patients is 3.8%. On the other hand, the Orsiro stent, a cobalt-chromium platform with ultrathin struts, has had favorable results in different clinical settings and patients with different characteristics]; specifically in a subgroup analysis in DM, a TLF rate of 3.5% was reported

Conditions

Diabetes Mellitus; Coronary Artery Disease; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Abluminus Sirolimus Eluting Stent System (ASES)

The Abluminus sirolimus eluting stent manufactured by Envision and distributed by Concept Medical.

Group Type: ACTIVE_COMPARATOR

Abluminus Sirolimus Eluting Stent System (ASES)

Intervention Type: DEVICE

The procedure will be conducted in accordance with the CE mark instructions for use for the ASES.

The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

The Orsiro sirolimus eluting stent manufactured by Biotronik.

Group Type: EXPERIMENTAL

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

Intervention Type: DEVICE

The procedure will be conducted in accordance with the CE mark instructions for use for the OSES.

The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Interventions

Orsiro Sirolimus Eluting Coronary Stent System (OSES)

The procedure will be conducted in accordance with the CE mark instructions for use for the OSES.

The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Intervention Type: DEVICE

Abluminus Sirolimus Eluting Stent System (ASES)

The procedure will be conducted in accordance with the CE mark instructions for use for the ASES.

The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women over 18 years of age.
• Provide informed consent and agree to follow up as stipulated in the protocol.
• Diabetes mellitus. Whether it is DM 1 or 2 previously diagnosed or newly diagnosed by:

• Fasting glucose> 126 mg / dl (for study terms, fasting will be defined as the absence of caloric intake for> 8 hours)
• Tolerance curve to glucose (75 grams of glucose orally) with a glycemia at 2 hours> 200 mg / dl or,
• HbA1C> 6.5%.
• Coronary artery disease including chronic coronary syndrome, silent ischemia, or non-ST-segment elevation acute coronary ischemic syndrome.
• Presence of 1 or more de novo coronary lesions in native coronary arteries with a site of maximum stenosis> 50% that may be amenable to stenting; without limitation in the number of lesions or vessels affected.

Exclusion Criteria

• Cardiogenic shock.
• Allergy to acetylsalicylic acid, clopidogrel, ticagrelor, prasugrel, heparin, sirolimus or contrast medium, which cannot be adequately premedicated.
• Acute ST-segment elevation myocardial infarction candidate for primary or urgent coronary angioplasty.
• Left main coronary artery disease.
• In-stent restenosis.
• Lesions in venous or arterial grafts.
• Surgery (cardiac or non-cardiac) planned within 6 months of PCI, unless dual antiplatelet therapy can be continued in the periprocedural period.
• Inability to provide informed consent.
• Life expectancy <1 year

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Cardiologia Ignacio Chavez

OTHER

Sponsor Role: lead

Responsible Party

Julio Ivan Farjat Pasos

Co-Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guering Eid Lidt, MD

Role: STUDY_DIRECTOR

Instituto Nacional de Cardiología Ignacio Chávez

Julio I Farjat Pasos, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiología Ignacio Chávez

Walter O Magaña Ornelas, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiología Ignacio Chávez

Alejandra D Portillo Romero, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiología Ignacio Chávez

José A Ayón Martínez, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Cardiología Ignacio Chávez

Locations

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Tlalpan, Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Alejandra D Portillo Romero, MD

Role: CONTACT

aleportilloromero@gmail.com

+52 55 5573 2911 ext. 21217

Guering Eid Lidt, MD

Role: CONTACT

guering@yahoo.com

55 5573 2911 ext. 21217

Facility Contacts

Alejandra D Portillo Romero, MD

Role: primary

aleportilloromero@gmail.com

+52 55 5573 2911 ext. 21217

Guering Edit Lid, MD

Role: backup

guering@yahoo.com

+52 55 5573 2911 ext. 21217

Other Identifiers

INCAR-DG-DI-342-2020

Identifier Type: -

Identifier Source: org_study_id